BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 58ODX52ID

    MDR report key: 2907770 · Received January 10, 2013

    Report

    Report Number
    0001825034-2013-00073
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    January 30, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00070-1 / 00073-1).

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EVENTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS" NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00070 / 00073).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 RECEIVING A M2A MAGNUM HIP SYSTEM. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, AND METALLOSIS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO LOOSENING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 RECEIVING A M2A MAGNUM HIP SYSTEM. SUBSEQUENTLY, PATIENT¿S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, AND METALLOSIS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO LOOSENING. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012 DUE TO INFECTION AND GRAYISH STAINED MATERIAL CONSISTENT WITH METAL DEBRIS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, FEMORAL STEM, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND ANTIBIOTIC MOLDS WERE IMPLANTED. THE PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS TO REMOVE THE ANTIBIOTIC SPACER MOLDS AND TO IMPLANT BIOMET PRODUCT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13453 M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 442870

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R